Clinical trial · Interventional
Effectiveness and Safety Study on Different Timing of Preventive Ileostomy Closure After Surgery for Rectal Cancer
A Single Center, Open, Randomized Clinical Trials, Effectiveness and Safety Study on Different Timing of Preventive Ileostomy Closure After Total Mesorectal Excision for Middle and Low Rectal Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the appropriate timing to do preventive ileostomy closure after total mesorectal excision of rectal cancer. To evaluate the effectiveness and safety of preventive ileostomy closure at different time (12 weeks / 24 weeks after radical resection of rectal carcinoma). This study was expected to demonstrate that the early preventive ileostomy closure after total mesorectal excision of rectal cancer does not increase the risk of complications.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| stoma closure at different times | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- stoma closure at different times
- description
- choose different times to do stoma closure after surgery for rectal cancer
- interventionNames
- Procedure: stoma closure at different times
Primary outcomes (1)
- measure
- Postoperative complication
- timeFrame
- within the first 2 weeks after surgery
Secondary outcomes (3)
- measure
- Postoperative quality of life
- timeFrame
- five years
- measure
- survival rate
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * sign the informed consent * postoperative pathology is rectal adenocarcinoma * primary middle and low rectal cancer patients (tumor distance from the anal margin is less than 10 cm) * underwent total mesorectal excision for rectal cancer with preventive loop ileostomy Exclusion Criteria: * postoperative pathology is not rectal adenocarcinoma (rectal neuroendocrine tumor, lymphoma, etc.) * postoperative pathologic staging of rectal cancer is I phase, II phase * underwent total mesorectal excision for rectal cancer without preventive loop ileostomy * emergency operation for rectal cancer * disease progression (local recurrence or distant metastasis, etc.) * anastomotic stenosis * serious system disease, including heart dysfunction, respiratory insufficiency, liver and kidney dysfunction, serious blood diseases * participate in other clinical trial * pregnancy or perinatal woman * combined with other malignant tumor * with a history of neurological and psychiatric disorders * patients with abnormal bone marrow suppression after chemotherapy
References
Publications (3)
- BACKGROUNDMatthiessen P, Hallbook O, Rutegard J, Simert G, Sjodahl R. Defunctioning stoma reduces symptomatic anastomotic leakage after low anterior resection of the rectum for cancer: a randomized multicenter trial. Ann Surg. 2007 Aug;246(2):207-14. doi: 10.1097/SLA.0b013e3180603024. PMID 17667498
- BACKGROUNDDindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. PMID 15273542
- BACKGROUNDTulchinsky H, Shacham-Shmueli E, Klausner JM, Inbar M, Geva R. Should a loop ileostomy closure in rectal cancer patients be done during or after adjuvant chemotherapy? J Surg Oncol. 2014 Mar;109(3):266-9. doi: 10.1002/jso.23493. Epub 2013 Nov 19. PMID 24249401